Name: DIN EN ISO 13485 2021 manual / template download now
SKU: 978-3-947669-14-1
Price: 136.00 EUR
Availability: InStock

DIN EN ISO 13485:2021 – Medical device production & service / to the description

You do not place medical devices on the market in accordance with MDR 2017/745, but have customers who require certification in accordance with DIN EN ISO 13485:2021.

Target group:

Manufacturers of medical devices or parts thereof without placing a medical device on the market themselves.
Finisher of medical products such as coating, assembly, production and much more.
Service providers for medical device manufacturers such as training, installation, maintenance and much more.

Conditions:

No supplementary deliveries
Right of return
Payment by invoice or PayPal
Digital delivery (*.zip)

Table of contents / Reading sample

All files are available in MS Office. No license fees or follow-up costs!

136,00 €

incl. VAT

The template takes into account:
☐ Development
☒ Production
☒ Sales / Trade
☒ Service
☒ Service / Maintenance

Structure Directories:

Manual (8 chapters),
Process examples – templates (60),
Work instruction examples (8),
Forms / Evidence (55)
ISO 13485 2021 Supplement to ISO 9001

The numbering corresponds to the underlying standard DIN EN ISO 13485 2021 . This makes it easy to assign them to the standard.

Special features:

We have filled the forms and verification forms with examples. This simplifies the creation and adaptation.
The disciplines of production, sales and services are taken into account (no development).
The structure of the set of rules is based on the standard: this means that all documents are numbered according to the corresponding standard point.
The effort required to adapt the set of rules, taking into account MS Office knowledge, is low. For companies with existing certification, the regulations serve to meet the new standard requirements.
We have added a supplementary directory to enable certification in accordance with ISO 9001. This enables an Integrated Management System (IMS) from DIN EN ISO )001:2015 and DIN EN ISO 13485 2021.

Do you need support with implementation? We are happy to help. Please contact us.